177Lu-PSMA-I＆T PSMA Radioligand Therapy in Metastatic Castration-Resistant Prostate Cancer

Last updated: December 4, 2019
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT04188587
fengwang-177LU-PSMA
  • Ages 18-90
  • Male

Study Summary

The purpose of this study is to determine the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.

Eligibility Criteria

Inclusion

Entry criteria

  1. ECOG score: 0-1 point

  2. Lymph and skeletal metastases or visceral metastases that cannot be removed surgically

  3. The disease continues to progress after treatment with ADT, chemotherapy, radiotherapy, or abiraterone and emzaludine 4.68Ga PSMA-11 PET / CT showed that there was significant radioactivity uptake in tumor tissues and metastases [SUVmax> 7], which was significantly higher than that in the liver.

Exclusion criteria

  1. Previous treatment with any of the following within 6 months of randomization:

Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation. Previous PSMA-targeted radioligand therapy is not allowed.

  1. Hemoglobin<80g/L;Hemameba<2.5×109/L;Thrombocyte<70g/L

  2. Glomerular filtration rate<50ml/min

  3. Serum creatinine>130umol/L;Total bilirubin>2mg/L;Albumin<30g/L.

  4. International normalized ratio（INR）>1,5

  5. Alanine aminotransferase, aspartate aminotransferase is 5 times larger than normal value

Study Design

Total Participants: 30
Study Start date:
January 01, 2019
Estimated Completion Date:
August 31, 2020

Study Description

Prostate specific membrane antigen(PSMA) targeted therapy brings new hope to the patients with metastatic castration-resistant prostate cancer (mCRPC). Here, we reported the safety and efficacy of 177 Lu -labeled PSMA ligand(PSMA-I＆T) in the treatment of mCRPC in Asianethics.

Prostate cancer is the most common cancer diagnosed in older men with recent data .PSMA is a type II transmembrane glycoprotein，overexpressed up to 100 to 1000 times higher than normal prostate cells in prostate cancer cells and is correlated with higher-grade cancers, metastatic disease and hormone refractory disease. Lutetium-177 (177Lu)-PSMA (LuPSMA) is a novel and highly targeted systemic RLT for progressive mCRPC. Upon binding of LuPSMA to the cell membrane, endocytosis is triggered, concentrating the tumouricidal effects of the radioisotope activity internally within malignant cells.

This is a single-institution, single-arm phase 2 clinical trial. Patients will receive PRLT Treatment. The follow-up period was followed up to assess safety and effectiveness.

Connect with a study center

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Active - Recruiting

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